Promising Interim Data from Alterity Therapeutics' Phase 2 Clinical Trial in MSA
ATH (ATH) Share Update July 2024 Wednesday 17th
Alterity Therapeutics Reports Promising Interim Data from Phase 2 Clinical Trial
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) has announced promising interim data from its ATH434-202 Phase 2 clinical trial in patients with Multiple System Atrophy (MSA), showing significant improvements in daily living activities and neurological symptoms.
Instant Summary:
- 43% of participants showed improvement on the UMSARS Activities of Daily Living Scale.
- 29% of participants had stable or improved neurological symptoms.
- Objective biomarkers demonstrated improvement consistent with clinical findings.
- ATH434 was well-tolerated with no safety signals detected.
Interim Data Highlights
The interim analysis included clinical and biomarker data on 7 participants treated with ATH434 for 6 months and neuroimaging data on 3 participants treated for 12 months. After 6 months of treatment, 43% of participants showed improvement on the UMSARS, indicating reduced disability on activities of daily living. Over the same period, 29% of participants had stable or improved neurological symptoms.
Importantly, clinical responders had reduced accumulation of iron on MRI in the substantia nigra, putamen, and globus pallidus, and stable levels of NFL, a marker of axonal injury, compared to participants who declined.
Clinical and Biomarker Assessments
Unified MSA Rating Scale Part I, historical review (UMSARS): 43% (3/7) of participants had lower scores (improvement) on the UMSARS that assesses activities of daily living affected in MSA, such as speech, swallowing, walking, and urinary/bowel function. Mean UMSARS scores increased by 1.7 points over 6 months, which compares favorably to historical data showing an increase of 3.9 points over the same period.
Global Impression of Change: 29% (2/7) of participants stabilized or improved on the Clinical Global Impression of Change (CGIC) scale, and 29% (2/7) also stabilized or improved on the Patient Global Impression of Change (PGIC) scale.
Safety and Tolerability
ATH434 was generally well-tolerated by study participants, with most adverse events being mild to moderate in severity. No serious adverse events related to the study drug were reported.
Biomarker Assessments
Brain Volume: At Month 6, there were similar declines in brain volume in all participants, consistent with the nature of MSA. However, in clinical responders, brain volume was stable between Month 6 and Month 12.
Iron Content: Iron content in the substantia nigra was stable over 12 months in clinical responders.
Fluid Biomarkers: Neurofilament Light Chain (NfL) levels were stable in clinical responders, while those who declined clinically had increased NfL levels.
The positive interim data from the ATH434-202 trial suggests that ATH434 has the potential to modify the course of Multiple System Atrophy, a rapidly progressive and unremitting disease. This could lead to increased investor confidence in Alterity Therapeutics' development program and positively impact the company's stock price.
Investor Reaction:
Dr. David Stamler, CEO of Alterity Therapeutics, expressed optimism about the interim results, noting that the data reinforces the company's approach in their randomized trial. Dr. Daniel Classen, principal investigator for the study, also highlighted the importance of the objective biomarkers in supporting the clinical observations.
Conclusion:
Investors should monitor the final 12-month data expected in the first half of 2025 and assess the potential long-term impacts on their portfolios. Alterity Therapeutics' strategic response to these interim results will be crucial in maintaining investor confidence.